Subject non compliance (or product failure?) [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2020-07-16 14:30 (383 d 03:53 ago) – Posting: # 21714
Views: 1,326

Hi Loky do,

» if a subject didn't have any evaluable concentrations for only test product all intervals are BLQ and according to our SOPs and SAP, the BLQ is considered "zeros", could be excluded from PK …

What does you protocol say? See also this recent thread.
Even if the outcome of investigations is negative, likely it would ring the alarm bells of regulators, esp. since you found no concentrations after the test product. What if it was a product failure (example: bad coating of a gastro-resistant PPI)? Regulators are more relaxed about the reference product since it “works” in clinical practice despite occasional failures. The EMA accepts exclusion in exceptional cases:(my emphases)

In your case (test only) cards are stacked against you.

» … and statistical analysis?

$$\lim_{x \to 0} \log x=-\infty.$$For simplicity we can say that \(\small{\log 0}\) is undefined. Hence, the common analysis based on log transformed PK metrics without excluding the subject is not possible at all.

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Helmut Schütz

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